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Hysteroscopic Evaluation of Cesarean Scar Defect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780699
Recruitment Status : Unknown
Verified December 2018 by Radwa Rasheedy Ali, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : December 19, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Study Description
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Brief Summary:
The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.

Condition or disease Intervention/treatment
Cesarean Scar Defect Procedure: Diagnostic hysteroscopic examination

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Hysteroscopic Evaluation of Cesarean Scar Defect Features & Its Correlation With Women Complaints
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Groups and Cohorts
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Intervention Details:
  • Procedure: Diagnostic hysteroscopic examination
    The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features

Outcome Measures
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Primary Outcome Measures :
  1. cesarean section scar defect shapes [ Time Frame: at least six months after CS ]
    different shapes of CS defect and its relation to post menstrual spotting


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.
Criteria

Inclusion Criteria:

  1. Age between 18 and 35 years.
  2. Had at least one prior cesarean section

Exclusion Criteria:

  1. History of uterine surgery that could change the cavity anatomy.
  2. Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
  3. Recent intra-uterine contraceptive device (IUCD) in place.
  4. Known history of endometriosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780699


Contacts
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Contact: Radwa R Ali, MD 01283492979 ext 02002 radwaebed@yahoo.com

Locations
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Egypt
AinShams university maternity hospital Recruiting
Cairo, Abbassya, Egypt, 11566
Contact: Radwa R Ali, MD         
Sponsors and Collaborators
Ain Shams University
More Information
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Responsible Party: Radwa Rasheedy Ali, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03780699    
Other Study ID Numbers: Ain Shams University H
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No